1.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
2.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
3.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
4.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
5.First-in-Human Trial of Photodynamic Therapy for Spinal Cord Malignant Astrocytoma: Study Protocol
Toshiki ENDO ; Yoshiharu TAKAHASHI ; Taketo NISHIZAWA ; Tatsuya SASAKI ; Aya SATO ; Shinjiro FUKAMI ; Satoshi MIYATA ; Jiro AKIMOTO
Neurospine 2024;21(4):1276-1282
Our extensive basic research on photodynamic therapy (PDT) application in models of intracranial malignant astrocytoma led to its clinical application for intracranial malignant astrocytoma in Japan. Having considered the safety and effectiveness of this pathology, we initiate a first-in-human clinical study of PDT for spinal cord malignant astrocytoma. This study has an open-label, single-arm design. The initial follow-up period is 12 months, at the end of which we will quantify survival after PDT for spinal cord malignant astrocytoma as primary objective. The secondary objective is to quantify the overall progression-free survival of treated patients and the percentage of patients surviving 6 months after PDT without recurrence. Twenty patients suffering from spinal cord malignant astrocytoma will be recruited. In particular, 10 of those should be newly diagnosed World Health Organization grade 4. After obtaining consent, each patient will receive a single intravenous injection of talaporfin sodium (40 mg/m2) 1 day before tumor resection. One day after completing tumor removal, the residual lesion and/or resection cavity will be irradiated using a 664-nm semiconductor laser with a radiation power density of 150 mW/cm2 and a radiation energy density of 27 J/cm2. The procedure will be performed 22–26 hours after talaporfin sodium administration. This study protocol has been reviewed and approved by the Certified Committee in the Japanese Ministry of Health, Labor, and Welfare University Hospital Medical Information Network Clinical Trials Registry (Japan Registry of Clinical Trials number, jRCT2021220040).
6.The Role of Pharmacist as Part of the Parkinson’s Disease Expert Home
Naohiro SUGITA ; Tamiko SHOGEN ; Kou SATO ; Chisato KAMEDA ; Misa NISHI ; Keiko YASUDA ; Keita YAMASHIRO ; Yoshiharu OHTA ; Masako HASHIMOTO
Japanese Journal of Social Pharmacy 2022;41(2):106-113
Objective : Parkinson’s disease (PD) is a disease treated by polytherapy. This time, the authors report the role of pharmacists in one of the few Parkinson’s disease facilities in Japan (https://sunwels.jp/pdhouse/; abbreviated as PD House), which was born from the voices of PD patients. Methods : The backgrounds of 52 patients admitted to the PD House and prescriptions for them were analyzed to mainly clarify: the percentages of patients aged 75 or over and those using 7 or more prescribed drugs; and frequently used drugs to be carefully administered to the elderly. The approaches provided by pharmacists through interprofessional collaboration were also analyzed. Results : The percentages of patients aged 75 or over and those receiving benefits for individuals requiring care were 71.2 and 92.3%, respectively. Those using 7 or more prescribed drugs accounted for 75.0%. In multidisciplinary collaboration, pharmacists were involved in not only pharmacotherapy but also nutritional evaluation of patients with severe nutritional disorders, proposal of appropriate nutritional therapy, understanding of swallowing function, and appropriate medication teaching. Conclusion : The actual situation of PD patients, where they used multiple drugs, and their backgrounds suggest that interprofessional collaboration is indispensable for PD treatment, and the roles of pharmacists were shown to be important.
7.A Case of Amylase-producing Small Cell Lung Cancer Complicated by Cushing's Syndrome
Ayana ISHIGURO ; Makoto NAKAO ; Yoshiharu OZAWA ; Yuto SUZUKI ; Yusuke SAKAI ; Sosuke ARAKAWA ; Kohei FUJITA ; Hidefumi SATO ; Etsuko YAMAMORI ; Hideki MURAMATSU
Journal of the Japanese Association of Rural Medicine 2019;68(4):535-542
A 68-year-old man was admitted to our hospital with complaints of fatigue, polyuria, and loss of appetite, and was diagnosed with diabetic ketosis. Chest and abdominal computed tomography (CT) showed a pulmonary tumor on the right S3 and multiple liver tumors. Blood chemistry revealed elevated levels of amylase and hepatobiliary enzymes. Pathological examination of a biopsy specimen from the liver tumor showed a small cell carcinoma. Based on the imaging and pathological findings, we made a diagnosis of extensive disease small-cell lung cancer (ED-SCLC), cT1aN3M1b (HEP, ADR). Treatment with carboplatin and etoposide evoked partial response and the serum level of amylase decreased. Immunohistochemical staining of liver biopsy specimen was positive for amylase, leading to a diagnosis of SCLC with amylase production. About 22 months after the diagnosis of SCLC, he was admitted to our hospital with fatigue, muscular weakness, edema, and hyperpigmentation. Laboratory findings showed elevated serum levels of hepatobiliary enzymes, adrenocorticotropic hormone (ACTH), and cortisol, and a decreased serum potassium level. Urinary potassium level was elevated. Pituitary magnetic resonance imaging showed a normal morphology. We made a diagnosis of SCLC complicated by Cushing’s syndrome. We report this rare case of SCLC with amylase and ACTH production, which was detected in the course of treatment of SCLC.
8.Evaluation and Exposure Dose Management during Diagnostic Radiography
Kunihiro TANI ; Yuki IZUMIKAWA ; Yoshiharu SATO ; Fumiaki SATO
Journal of the Japanese Association of Rural Medicine 2016;65(4):816-822
We measured the exposure dose to different parts of the body during general radiography in our hospital and examined the radiographic conditions in comparison with the dose limitation goal announced during a conference held by The Japan Association of Radiological Technologists. In recent years, many researchers have become interested in the exposure dose during radiographic examination. General radiography was discussed at the conference and there is now more certification of facilities with measures aimed at radiation dose reduction. We measured the exposure dose to different parts of the body for 27 items by using a dosimeter and radiation dose estimation software. Basically, radiography conditions in our hospital were below the limitation goal, although some items were above the limitation goal. Even though some were above the limitation goal, we consider that they are within the acceptable range if they are necessary for diagnosis. Through this measure and estimates, all radiation technologists in our hospital have become more conscious of the need to reduce exposure dose.
9.Hemolytic Anemia Associated with a Teflon Felt Strip on a Proximal Anastomotic Site for Aortic Replacement in a Patient with Aortic Dissection
Chiho Tokunaga ; Yoshiharu Enomoto ; Shinya Kanemoto ; Fujio Sato ; Shonosuke Matsushita ; Yuji Hiramatsu ; Yutaka Watanabe ; Tomoaki Jikuya ; Yuzuru Sakakibara
Japanese Journal of Cardiovascular Surgery 2011;40(4):181-183
A 61-year-old man was referred to our hospital for treatment of hemolytic anemia after ascending aortic replacement aortic dissection. Cine mode magnetic resonance imaging (MRI) showed stenosis at the proximal anastomostic site of a Teflon strip. We diagnosed hemolytic anemia induced by collision of red blood cells on the inverted felt strip. Conservative therapy with Sarpogrelate and β-blockers was effective to treat his hemolytic anemia. However, 7 years later he was re-admitted because of infective endocarditis at the aortic valve, and underwent aortic root replacement. Intraoperative findings showed a stiff and inverted Teflon felt strip causing stenosis of the proximal anastomosis. Hemolytic anemia should be considered a rare complication of using a Teflon felt strip to reinforce anastomosis for acute aortic dissection.
10.Analysis of risk factors for dental caries in infants: a comparison between urban and rural areas.
Keiko OHSUKA ; Naohito CHINO ; Haruo NAKAGAKI ; Izumi KATAOKA ; Yoshiharu OSHIDA ; Isao OHSAWA ; Yuzo SATO
Environmental Health and Preventive Medicine 2009;14(2):103-110
OBJECTIVESThis study investigated the incidence of caries in infants and explored the risk factors related to noteworthy variations between urban and rural areas.
METHODSSubjects were 232 infants (111 males and 121 females) aged 1.6 and 3 years born in "N" town between the fiscal years of 1997 and 2001. Infants aged 1.6 and 3 years had 99.6 and 100% participation in health checkups, respectively. Of the total, 148 and 84 infants were living in the urban and rural areas, respectively, of "N" town.
RESULTSCaries incidence and the average number of carious teeth (decayed/missing/filled teeth, dmft) for infants aged 1.6 years were significantly higher in the rural area than in the urban area, indicating that environmental factors that predispose infants to develop dental caries exist in the rural area. In addition, logistic regression analysis for infants in each of the two areas revealed that risk factors of the child-care environment, for example living with grandparents and brushing by parents, stood in marked contrast with each other. Moreover, the odds ratio of the risk factor dozing off while drinking showed a marked difference between the areas, although this risk factor was common in both areas.
CONCLUSIONSThe results of this study indicated that several factors of the child-care environment, for example the daytime caring person, are related with caries development. Scientific elucidation of the risk factors that give rise to high prevalence of caries in specific regions and access to the whole picture of the disease mechanism may have great potential to lead to the development of effective countermeasures and to contribute to the reduction of dental caries in preschool children.


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